510(k) Report

Devices descending from DEN130003

33 later devices reach Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180041BioCode Gastrointestinal Pathogen Panel (GPP)Applied BioCode, Inc.20182—
+1K142033Verigene Enteric Pathogen Nucleic Acid Test (EP)Nanospere,Inc.201401
+1K140377Xtag Gastrointestinal Pathogen Panel (GPP)/Xtag Data Analysis Software for GPP (Tdas GPP)Luminex Molecular Diagnostics, Inc.201401
+1K140407Filmarray Gastrointestinal (GI) PanelBiofire Diagnostics2014248
+1K123274Progastro SSCS AssayGen-Probe Prodesse, Inc.20134—
+2K251721Xpert GI PanelCepheid20260—
+2K251868Panther Fusion GI Bacterial AssayHologic20250—
+2K251993Panther Fusion GI Expanded Bacterial AssayHologic, Inc.20250—
+2K220062QIAstat-Dx Gastrointestinal Panel 2QIAGEN GmbH20244—
+2K182703EntericBio Dx AssaySerosep, Ltd.20190—
+2K190585Biocode Gastrointestinal Pathogen Panel (GPP)Applied BioCode, Inc.20191—
+2K152955Great Basin Shiga Toxin Direct TestGreat Basin Scientific, Inc.20160—
+2K143648BD MAX Enteric Parasite Panel, BD MAX InstrumentBecton, Dickinson and Company201521
+2K143005FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0Biofire Diagnostics, LLC2015127
+2K140111BD Max (TM) Enteric Bacterial Panel;BD Max (TM) InstrumentBecton, Dickinson and Company201432
+3K250358BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR…Becton, Dickinson and Company20250—
+3K252329QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel…QIAGEN GmbH20251—
+3K250324QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH20252—
+3K242877BioCode Gastrointestinal Pathogen Panel (GPP)Applied BioCode, Inc.20250—
+3K243813QIAstat-Dx GI Panel 2 Mini B&VQIAGEN GmbH20252—
+3K232672EasyScreen Gastrointestinal Parasite Detection KitGenetic Signatures Limited20240—
+3K220193BD MAX Enteric Parasite PanelBecton, Dickinson and Company20220—
+3K214122BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial PanelBecton, Dickinson and Company20221—
+3K181427BD MAX Enteric Viral Panel, BD MAX InstrumentBecton, Dickinson and Company201811
+3K173330PanNAT STEC TestMicronics, Inc.20180—
+3K160459FilmArray Gastrointestinal Panel (GI) for use with FilmArray TorchBiofire Diagnostics, LLC201696
+4K254032QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel…QIAGEN GmbH20260—
+4K230404BIOFIRE FILMARRAY Gastrointestinal (GI) PanelBiofire Diagnostics, LLC202333
+4K220607BD MAX Enteric Viral PanelBecton, Dickinson and Company20220—
+4K170308BD MAX Extended Enteric Bacterial Panel, BD MAX SystemBecton, Dickinson and Company201721
+5K242367BIOFIRE FILMARRAY Gastrointestinal (GI) PanelBiofire Diagnostics, LLC20242—
+6K253722LIAISON PLEX Gastrointestinal Flex AssayLuminex Corporation20260—
+6K243885BIOFIRE FILMARRAY Gastrointestinal (GI) Panel MidBiofire Diagnostics, LLC20250—